Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1490-2014·Announced 2014-08-06

FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions

Dermamedics, L.L.C. is recalling Dermamedics and Therametics Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the primary issue is regulatory (unapproved status) rather than a specific physical hazard like contamination or structural failure.

Plain-English summary

Dermamedics, L.L.C. is recalling Dermamedics Complexion Repair Topical Rehydrating Emulsion (SKU DM 1011) and Therametics Complexion Repair Topical Rehydrating Emulsion (SKU CR002). These products were distributed in 50 ml containers nationwide under all lot codes.

The FDA has determined that these products are unapproved new drugs and misbranded because they were marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This recall is classified as FDA Class II.

Consumers who have these products should stop using them and contact Dermamedics, L.L.C. for further instructions or a refund.

The recalled product

Product: Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
Manufacturer: Dermamedics, L.L.C.
Category: Drug — Topical
Hazard: unapproved-drug
mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

all lot codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Dermamedics, L.L.C. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Dermamedics, L.L.C.

See all →

Moderate
Dermamedics Serum Recalled for Lacking FDA Approval
FDA (Drugs) · 2014-08-06
Moderate
FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions
FDA (Drugs) · 2014-08-06
Moderate
Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval
FDA (Drugs) · 2014-08-06
Moderate
Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval
FDA (Drugs) · 2014-08-06
Moderate
FDA Recalls Unapproved Dermamedics and Therametics Baby's Relief Creams
FDA (Drugs) · 2014-08-06

Same hazard · unapproved drug